MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-10 for H. S. MEDICAL INC. AMICA MICROWAVE ABLATION PROBE APK14150T19V5 manufactured by H. S. Hospital Services S. P. A..
[174888151]
Microwave ablation of pt with hcc, liver, seg iv 4a, w/ cirrhosis, 1. 0 cm lesion was ablated at 100 watts / 15 mins. Track ablation at 40 w/4 seconds. After amica 14 gauge, 15 cm probe was removed, dr noticed that the distal tip of the probe remained at the edge of the tumor ablation zone verified by ct. The post ct scan with contrast showed good coverage of the lesion. No adverse events noted for the pt at this time. Fda safety report id # (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092184 |
| MDR Report Key | 9581196 |
| Date Received | 2020-01-10 |
| Date of Report | 2020-01-08 |
| Date of Event | 2020-01-08 |
| Date Added to Maude | 2020-01-13 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | H. S. MEDICAL INC. AMICA MICROWAVE ABLATION PROBE |
| Generic Name | SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES |
| Product Code | NEY |
| Date Received | 2020-01-10 |
| Returned To Mfg | 2020-01-08 |
| Model Number | APK14150T19V5 |
| Catalog Number | APK14150T19V5 |
| Lot Number | 37011 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | H. S. HOSPITAL SERVICES S. P. A. |
| Manufacturer Address | VIA ANGELA VACCHI, 23 APRILIA LT 04011IT IT 04011 IT |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-10 |